A 6-month safety and benefit study of inhaled fluticasone propionate/ salmeterol combination versus inhaled fluticasone propionate in the treatment of 6,200 pediatric subjects 4-11 years old with persistent asthma

Trial Profile

A 6-month safety and benefit study of inhaled fluticasone propionate/ salmeterol combination versus inhaled fluticasone propionate in the treatment of 6,200 pediatric subjects 4-11 years old with persistent asthma

Completed
Phase of Trial: Phase IV

Latest Information Update: 11 Feb 2018

At a glance

  • Drugs Salmeterol/fluticasone propionate (Primary) ; Fluticasone propionate
  • Indications Asthma
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms VESTRI
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 20 Dec 2017 The FDA also approved updates to the Warnings and Precautions section of labelling for the ICS/LABA class, according to a GlaxoSmithKline media release.
    • 20 Dec 2017 According to a GlaxoSmithKline media release, based on the data from four trials (including AUSTRI, SAS115359 and VESTRI, SAS115358) submitted by three companie, the US Food and Drug Administration (FDA) has approved labelling changes to remove the boxed warning from inhaled corticosteroid (ICS) / long-acting beta2 agonist (LABA) combination medicines, including BREO ELLIPTA (fluticasone furoate/vilanterol, FF/VI), ADVAIR DISKUS (fluticasone propionate/salmeterol, FSC) and ADVAIR HFA.
    • 27 Aug 2016 Results from this trial will be presented at the European Respiratory Society (ERS) International Congress 2016, according to a GlaxoSmithKline plc media release.
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